Regulatory Filings and Data Sample Clauses

Regulatory Filings and Data. EPIZYME, at its sole cost, shall have the right and responsibility, in consultation with EISAI, for preparing, filing and maintaining all regulatory filings and Regulatory Approvals necessary for the Development or Commercialization of Licensed Compounds and Licensed Products in the Field in the EPIZYME Territory, including applicable INDs and NDAs. EPIZYME shall own all such regulatory filings and Regulatory Approvals relating to the EPIZYME Territory. EISAI, at its sole cost, shall have the right and responsibility, in consultation with EPIZYME, for preparing, filing and maintaining all regulatory filings and Regulatory Approvals necessary for Japan-Specific Development Activities or Commercialization of Licensed Compounds and Licensed Products in the Field in the EISAI Territory, including applicable INDs and NDAs. EISAI shall own all such regulatory filings and Regulatory Approvals relating to the EISAI Territory.
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Regulatory Filings and Data. EISAI shall have the right and responsibility, in consultation with EPIZYME, for preparing, filing and maintaining all regulatory filings and Regulatory Approvals necessary for the Development or Commercialization of Licensed Compounds or Licensed Products in the Field in the Territory, including applicable INDs and NDAs. EISAI shall own all such regulatory filings and Regulatory Approvals.
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Regulatory Filings and Data. GSK shall be solely responsible for preparing, filing and maintaining all regulatory filings (including pricing and reimbursement approvals) and Regulatory Approvals necessary for the Development, manufacture or Commercialization of Licensed Compounds, Licensed Products and Diagnostic Products in the Field in the Territory. GSK shall own all such regulatory filings and Regulatory Approvals.
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Regulatory Filings and Data. (a) Novo Nordisk shall be solely responsible for the filing of and shall be the sole owner of all regulatory submissions and related activities, including clinical applications and marketing applications for Licensed Product(s). Novo Nordisk shall solely own and be responsible for all regulatory documents and registrations related to Licensed Product, including all clinical trial applications and marketing applications filed with any regulatory authority in any jurisdiction. PCYC shall exert diligent efforts to cooperate upon Novo Nordisk’s request with the making of filings.
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Regulatory Filings and Data. In the event that Felicitex exercises its Option, the applicable provisions regarding “Regulatory Filings and Data” of the Exclusive License Agreement shall apply. With view to the Development, Manufacturing or Commercialization of Program Compounds other than Optioned Compounds, Selvita shall have the sole right and responsibility for preparing, filing and maintaining all Regulatory Material, Regulatory Dossiers and Regulatory Approvals necessary for the Development, Manufacturing or Commercialization of such Program Compounds and pharmaceutical products comprising or based upon such Program Compounds in the Territory, including applicable INDs and NDAs. In such case, Selvita or its Affiliate or Sublicensee shall solely own all such Regulatory Material, Regulatory Dossiers and Regulatory Approvals.
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Regulatory Filings and Data. GSK shall, to the extent permitted by applicable Law, assign and transfer (as soon as reasonably practicable) to Alector all Regulatory Filings and Regulatory Approvals for Licensed Products that are held or controlled by or under authority of GSK or its Affiliates or Sublicensees (unless such Sublicensees are to become Sublicensees of Alector in accordance Section 12.6.7) as of the effective date of termination, and shall take such actions and execute such other instruments, assignments and documents as may be necessary to effect the transfer of rights under such Regulatory Filings and Regulatory Approvals to Alector. GSK shall also (as soon as reasonably practicable) transfer control of and responsibility for maintaining the global safety database for Licensed Products to Alector, and Alector shall accept 112 *** Certain information has been excluded from this agreement because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. such transfer and responsibility. GSK shall cause each of its Sublicensees to (as soon as reasonably practicable) transfer any such Regulatory Filings and Regulatory Approvals to Alector if this Agreement terminates. If applicable Law prevents or delays the transfer of ownership of any such Regulatory Filing or Regulatory Approvals to Alector, GSK shall grant, and does hereby grant, to Alector an exclusive and irrevocable right of access and reference to such Regulatory Filing and Regulatory Approvals, and shall reasonably cooperate to make the benefits of such Regulatory Filings and Regulatory Approvals available to Alector or its designee(s), provided that GSK shall not be obliged to maintain any such Regulatory Filing or Regulatory Approval or to provide reasonable cooperation to Alector beyond the date that is [***] [***] following the effective date of expiration or termination of this Agreement, provided such period may be extended provided that Alector reimburses GSK’s reasonable costs incurred in connection with such maintenance and cooperation during any such period. As soon as reasonably practicable after the effective date of termination (or, if reasonably requested by Alector after notice of termination), GSK shall provide or make available to Alector (in electronic form to the extent reasonably requested by Alector and available to GSK in such form) copies of: (i) all such Regulatory Filings and Regulatory Approvals; and (ii) of all Data and other Know-How in its or its Affiliat...
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Regulatory Filings and Data. JBI shall promptly assign and transfer to Pharmacyclics all Regulatory Filings and Regulatory Approvals for Products that are held or controlled by or under authority of JBI or its Affiliates or Sublicensees as of the effective date of termination, and shall take such actions and execute such other instruments, assignments and documents as may be necessary to effect the transfer of rights under such Regulatory Filings and Regulatory Approvals to Pharmacyclics. JBI shall also promptly transfer control of and responsibility for maintaining the global safety database for Products to Pharmacyclics, and Pharmacyclics shall accept such transfer and responsibility. JBI shall cause each of its Sublicensees to promptly transfer any such Regulatory Filings and Regulatory Approvals to Pharmacyclics if this Agreement terminates. If applicable Law prevents or delays the transfer of ownership of any such Regulatory Filing or Regulatory Approvals to Pharmacyclics, JBI shall grant, and does hereby grant, to Pharmacyclics an exclusive and irrevocable right of access and reference to such Regulatory Filing and Regulatory Approvals for the Products, and shall cooperate fully to make the benefits of such Regulatory Filings and Regulatory Approvals available to Pharmacyclics or its designee(s). Within [**].
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Regulatory Filings and Data. BMS shall transfer, and shall cause each of its Affiliates and sublicensees to transfer, to Nektar any and all regulatory filings and Regulatory Documentation (other than INDs and related data, the obligations with respect to which are set forth in Section 16.6(b)(ii)), directly related to any Nektar Compound or Product, and upon Nektar’s request, shall make available to Nektar any other relevant information and documentation reasonably related to such regulatory filings and Regulatory Documentation (including non-clinical, preclinical and clinical data that are held by or reasonably available to BMS, its Affiliates or sublicensees), but without any obligation to transfer BMS Regulatory Documentation. BMS shall take such actions an execute such other instruments, assignments and documents as may be necessary to effect the transfer of rights under such regulatory filings and Regulatory Documentation to Nektar. If Applicable Law prevents or delays the transfer of ownership of any such regulatory filings or Regulatory Documentation to Nektar, BMS hereby grants to Nektar an irrevocable right of access and Right of Cross Reference to such regulatory filings and Regulatory Documentation for the Products, and shall cooperate fully to make the benefits of such regulatory filings and Regulatory Documentation available to Nektar or its designee.
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Related to Regulatory Filings and Data

  • Regulatory Filings NYISO and Connecting Transmission Owner shall file this Agreement (and any amendment hereto) with the appropriate Governmental Authority, if required. Any information related to studies for interconnection asserted by Developer to contain Confidential Information shall be treated in accordance with Article 22 of this Agreement and Attachment F to the ISO OATT. If the Developer has executed this Agreement, or any amendment thereto, the Developer shall reasonably cooperate with NYISO and Connecting Transmission Owner with respect to such filing and to provide any information reasonably requested by NYISO and Connecting Transmission Owner needed to comply with Applicable Laws and Regulations.

  • Regulatory Materials (a) Alvogen shall have the sole right to control filing or submission of Regulatory Materials with the Regulatory Agencies in the Territory with respect to Product including the MAA Approval for Product and Regulatory Approvals in the Territory, subject to Section 3.2 and the oversight of and in consultation with the Executive Steering Committee, and [***]Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. shall be responsible for managing all communications and interactions with the Regulatory Agencies in the Territory with respect to Product in the Territory. In all cases, prior to the filing of any Regulatory Materials (including the MAA for Product) for Product with the applicable Regulatory Agency, Alvogen shall provide a copy thereof to Pfenex (through the Executive Steering Committee) for its review and comment. Pfenex shall have fifteen (15) Business Days from the date it receives a copy of any Regulatory Materials with respect to the Product to provide Alvogen with comments regarding such Regulatory Materials, unless the Regulatory Agencies in the Territory or Applicable Law requires that such Regulatory Material(s) be filed on a timeline that does not reasonably permit such advanced notice, in which case Pfenex shall have as much time as is reasonably practicable to provide Alvogen with comments. Alvogen shall consider all such comments in good faith. Alvogen shall, to the extent permitted by Applicable Law, provide Pfenex with (i) reasonable advanced notice (and in no event less than fifteen (15) Business Days’ advance notice whenever feasible) of substantive meetings with any Regulatory Agency in the Territory that are either scheduled with or initiated by or on behalf of Alvogen or its Affiliates, (ii) an opportunity to have a reasonable number (but at least two (2)) representatives participate in all substantive meetings with the Regulatory Agencies in the Territory with respect to Product, and in any case keep Pfenex informed as to all material interactions with the Regulatory Agencies in the Territory with respect to Product, and (iii) a copy of any material documents, information and correspondence submitted to or received from the Regulatory Agencies in the Territory with respect to Product as soon as reasonably practicable.

  • Regulatory Filings and Approvals Copies of all necessary governmental and third party approvals, registrations, and filings in respect of the transactions contemplated by this Agreement;

  • Regulatory Applications (a) Sky and SBI and their respective Subsidiaries shall cooperate and use their respective reasonable best efforts to prepare, within 45 days of the execution of this Agreement, all documentation and requests for regulatory approval, to timely effect all filings and to obtain all permits, consents, approvals and authorizations of all third parties and Governmental Authorities and Regulatory Authorities necessary to consummate the transactions contemplated by this Agreement. Each of Sky and SBI shall have the right to review in advance, and to the extent practicable each will consult with the other, in each case subject to applicable laws relating to the exchange of information, with respect to, and shall be provided in advance so as to reasonably exercise its right to review in advance, all material written information submitted to any third party or any Governmental Authority or Regulatory Authority in connection with the transactions contemplated by this Agreement. In exercising the foregoing right, each of the parties hereto agrees to act reasonably and as promptly as practicable. Each party hereto agrees that it will consult with the other party hereto with respect to the obtaining of all material permits, consents, approvals and authorizations of all third parties and Governmental Authorities or Regulatory Authorities necessary or advisable to consummate the transactions contemplated by this Agreement and each party will keep the other party apprised of the status of material matters relating to completion of the transactions contemplated hereby.

  • Regulatory Submissions From and after the Effective Date, NVS will[***] be responsible for (a) preparing, filing, and submitting, directly or through its Affiliates and permitted Sublicensees, all Regulatory Submissions for all Products in the Territory, and each material amendment or update thereto, in its name other than Jointly-Agreed Regulatory Submissions; and (b) interfacing, corresponding and meeting with Regulatory Authorities relating to Regulatory Submissions in the Territory for such Products; provided, that Regulatory Submissions and correspondence made to, and meetings held with, the FDA and EMA with respect to (i) [***] or (ii) [***] in each of (i) and (ii), will be prepared or conducted, as applicable, in collaboration with a representative from HMI’s regulatory team in accordance with this Article 7 (Regulatory Affairs); provided further that in all cases, such rights shall expressly exclude and not apply with Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission. Confidential Treatment Requested by Homology Medicines, Inc. respect to any data in Regulatory Submissions, correspondence, or meetings relating to any Other Components. Subject to Section 7.6 (Transfer of U.S. BLA for In-Vivo [***] Products), all Regulatory Approvals and Pricing Approvals for Products will be [***] owned by [***]. For all Products, NVS will timely inform HMI regarding the submission, receipt or denial of Regulatory Approval for such Product obtained or denied; provided, however, that NVS will inform HMI of such event prior to public disclosure of such event by NVS.

  • Regulatory Documentation Avidity and its Affiliates have generated, prepared, maintained and retained all Regulatory Documentation that is required to be maintained or retained pursuant to and in accordance with, to the extent applicable, good laboratory and clinical practice and Applicable Law and all such information is true, complete and correct in all material respects and what it purports to be. “Regulatory Documentation” means all: (a) applications (including all INDs and applications for Regulatory Approval), registrations, licenses, authorizations and approvals (including Regulatory Approvals); (b) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents with respect thereto, including all adverse event files and complaint files; (c) supplements or changes to any of the foregoing following Regulatory Approval; and (d) clinical and other data, including Clinical Trial data, contained or relied upon in any of the foregoing; in each case ((a), (b), (c) and (d)) relating to a Collaboration Target and Compounds Directed Against a Collaboration Target.

  • Regulatory Reports Flagstar and each of the Flagstar Subsidiaries have timely filed (or furnished, as applicable) all reports, forms, correspondence, registrations and statements, together with any amendments required to be made with respect thereto, that they were required to file (or furnish, as applicable) since January 1, 2018 with any Governmental Entity, including any report, form, correspondence, registration or statement required to be filed (or furnished, as applicable) pursuant to the laws, rules or regulations of the United States, any state, any foreign entity or any Governmental Entity, and have paid all fees and assessments due and payable in connection therewith, except where the failure to file (or furnish, as applicable) such report, form, correspondence, registration or statement or to pay such fees and assessments would not reasonably be expected to have, either individually or in the aggregate, a Material Adverse Effect on Flagstar. Subject to Section 9.15 and except for normal examinations conducted by a Governmental Entity in the ordinary course of business of Flagstar and the Flagstar Subsidiaries, no Governmental Entity has initiated or has pending any proceeding or, to the knowledge of Flagstar, investigation into the business or operations of Flagstar or any of the Flagstar Subsidiaries since January 1, 2018, except where such proceedings or investigations would not reasonably be expected to have, either individually or in the aggregate, a Material Adverse Effect on Flagstar. Subject to Section 9.15, there (x) is no unresolved violation, criticism, or exception by any Governmental Entity with respect to any report or statement relating to any examinations or inspections of Flagstar or any of the Flagstar Subsidiaries, and (y) has been no formal or informal inquiries by, or disagreements or disputes with, any Governmental Entity with respect to the business, operations, policies or procedures of Flagstar or any of the Flagstar Subsidiaries since January 1, 2018, in each case, except as would not reasonably be expected to have, either individually or in the aggregate, a Material Adverse Effect on Flagstar.

  • Reporting Obligations and Regulatory Approvals Applicable laws and regulations may require holders and beneficial owners of Shares, including the Holders and Beneficial Owners of ADSs, to satisfy reporting requirements and obtain regulatory approvals in certain circumstances. Holders and Beneficial Owners of ADSs are solely responsible for determining and complying with such reporting requirements and obtaining such approvals. Each Holder and each Beneficial Owner hereby agrees to make such determination, file such reports, and obtain such approvals to the extent and in the form required by applicable laws and regulations as in effect from time to time. Neither the Depositary, the Custodian, the Company or any of their respective agents or affiliates shall be required to take any actions whatsoever on behalf of Holders or Beneficial Owners to determine or satisfy such reporting requirements or obtain such regulatory approvals under applicable laws and regulations.

  • Necessary Filings 3 2.2. No Liens.........................................................3 2.3.

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